Senior Manager Quality Control

Senior Manager Quality Control

Requirements

• BA/BS in chemistry or biochemistry with 8 years of experience in a pharmaceutical company environment is required
• Demonstrated proficiency in analytical science by experience and/or education
• Experience working in a GMP environment, Quality Control and/or Quality Assurance
• Experience with the documentation of deviations and investigations in a GMP, quality controlled system
• Excellent written/oral communication and interpersonal skills
• Ability to negotiate and deal with others in a constructive manner
• Excellent organizational skills, focused self-starter, attention to details, team-oriented but able to work independently and proactively, and ability to multi-task
• Contract service provider experience is required
• Analytical Chemistry Manufacturing Controls (CMC) experience
• Knowledge of current Good Manufacturing Practices (GMPs)
• Experience in analytical development, validation and testing
• Knowledge of laboratory instruments (e.g. HPLC, GC, KF, IR, etc.)
• Statistical modeling experience
• Ability to travel 20% of time both domestically and internationally

Responsibilities

• Review and evaluate analytical test results for DS and DP
• Review and author analytical method protocols and validations for commercialized products
• Review and author analytical transfer protocols and reports between laboratories
• Author stability protocols and reports, including trending analysis of all data
• Negotiate and/or review stability related agreements
• Author and review analytical data summaries to support batch release and stability assessments
• Assist in the review of reports for regulatory filings
• Interact with CSPs to facilitate stability testing at contract laboratories for Acadia projects
• Coordinate stability studies including reporting of test results
• Familiar with extractable and leachable testing, container closure and packaging qualification and integrity testing, and cleaning verification method development and validation
• Conduct and document analytical deviations, out-of-specification (OOS), out-of-trend (OOT) investigations, and CAPA reports following SOPs and GMP guidelines
• Maintain training records per GMP training requirements
• Ability to maintain effectiveness in a changing environment
• Set high standards and assume responsibility for scheduling and successfully completing assignments and tasks as required by company time lines
• Interact and collaborate effectively with staff and CSPs
• Assist with data review at CSPs
• Assist with routine GMP audits of CSPs

Preferred Qualifications

• Experience in the review of DS and DP release and stability data, is desired
• Experience with stability, method development, validation and transfer related to the testing of DS and DP
• Experience with CMC sections for regulatory filings